GSM (Genitourinary Syndrome Of Menopause) Management In Breast Cancer Survivors

Postmenopausal breast cancer survivors who report at least one GSM sign or symptom will be
offered participation in an observational, prospective open label trial. Study duration will
be 6 months.

Evidence of GSM symptoms will be evaluated by a board certified gynecologist. Upon satisfying
the prescreen requirements, the patient's information will be forwarded to the
sub-investigator, who will confirm study eligibility and make the final determination
verifying the diagnosis of GSM. Participants will be using commercially available Replens
applied via prefilled applicator into the vagina and coconut oil applied at the vaginal
introitus and vulva. Both are to be administered by the patient 2 times per week, interval
between dosing to be approximately 2 days. Patients will be encouraged to apply Preseed,
coconut oil, or patient's personal lubricant of choice into the vagina prior to sexual
activity. Patients will record dosing on the Intake Diary. Outcome measures will include:

Quality of Life DIVA (Day-to-Day Impact of Vaginal Aging) questionnaire will be administered
at Baseline, at month 1, 3 and month 6. The FSFI (Female Sexual Function Index) questionnaire
will also be used for sexually active patients at the same time points. This is an
exploratory investigation. A planned paired T test will be applied to analyze the outcome and
regroup after data has been collected on the first 14 patients.

Inclusion Criteria:

1. Female

2. Postmenopausal women (defined as last menstrual period > 1 year ago or 6 months ago
with FSH >40) who have been diagnosed with breast cancer including in situ carcinoma
(DCIS, LCIS)

3. Have self-identified GSM signs and objective symptoms on baseline screening

4. Patients already using Replens™ or coconut oil will have a two week washout period
prior to starting study treatment.

5. Medical History review and Pelvic Exam by a board certified gynecologist for baseline
assessment OR medical records review by a board certified gynecologist or delegated
study staff to confirm diagnosis of GSM. If GSM is to be verified by medical record
review, the sub-investigator will make the final determination of eligibility.

Exclusion Criteria:

1. Use of any estrogen containing product within 4 weeks prior to screening

2. Endometrial hyperplasia, endometrial cancer, or other gynecologic malignancy

3. Patients with non GSM related signs and symptoms as verified by a board certified
gynecologist will be excluded.

4. Any concurrent illness or disorder that, per the opinion of the investigator, would
preclude the patient from meeting the study requirements.